Codeine Phosphate/ Mepyramine Maleate

Registered South African indications:

• Alleviation of cough

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Should not be taken simultaneously with monoamine oxidase inhibitors or within 14 days of stopping such treatment
• Acute asthma
• Respiratory depression
• Emphysema
• Bronchitis
• Excessive bronchial secretion
• Cyanosis
• Hypertension or heart disease, and heart failure secondary to chronic lung disease
• Acute alcoholism
• Diabetes
• Hyperexcitability
• Head injuries
• Raised intracranial pressure
• Hyperthyroidism
• Phaeochromocytoma
• Closed-angle glaucoma
• Should not be used after operations on the biliary tract

South African recommendations

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment

Elderly

• Reduce dosage
• Use cautiously in patients with inflammatory or obstructive bowel diseases, glaucoma, and prostatic hypertrophy

Use codeine phosphate with caution or in reduced doses in patients with:

• Hypothyroidism
• Adrenocortical insufficiency
• Prostatic hypertrophy
• Shock
• Obstructive bowel disorders
• Myasthenia gravis

Sedation and drowsiness

• May cause marked sedation, drowsiness, and impaired concentration, worsened by alcohol or CNS depressants
• Warn patients against operating vehicles or machinery or engaging in hazardous tasks

Chronic pulmonary disease and cough

• Do not use in chronic pulmonary disease, chronic cough, or cough with excessive phlegm unless advised by a doctor
• If cough persists over a week, recurs, or is accompanied by high fever, rash, or persistent headache, advise patients to consult a doctor

Constipation

• May cause or aggravate constipation. Risk increased with antidiarrhoeal agents like diphenoxylate
• Use cautiously in patients with obstructive bowel disorders, liver impairment, myasthenia gravis, prostatic hypertrophy, impaired renal function, narrow angle glaucoma, or porphyria

Dependence risk

• Risk of dependence with exceeding prescribed dose and prolonged, continuous use

Children

• Not recommended for use in children under 2 years

Dental health

• Long-term use of antihistamines can reduce salivary flow, increasing the risk of dental caries, periodontal disease, oral candidiasis, and discomfort

Masking

• Some antihistamines may mask damage caused by ototoxic medicines

Forms avail. in SA and covered in this monograph: syr

South African registered indications and dosages

Alleviation of cough

Codeine phosphate/ Mepyramine maleate
2.5/7 (mg/5ml)

• Oral (syr): 5-10ml, 4hrly

---

Do not exceed the recommended dose

Paed. forms avail. in SA and covered in this monograph: syr

South African registered indications and dosages

Alleviation of cough

Codeine phosphate/ Mepyramine maleate
2.5/7 (mg/5ml)

Younger than 2 years

• Not recommended for use

2 years or older

• Oral (syr): 2.5-5ml, 4hrly

---

Do not exceed the recommended dose

Pregnancy

South African recommendations

• Caution
• Safety for use in pregnancy has not been established

Breastfeeding

South African recommendations

• Caution; not recommended
• Not recommended in lactation

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no dose adjustment recommended

South African recommendations

• Caution; no dose adjustment recommended

South African recommendations

• Caution; dose adjustment recommended
  The dosage should be reduced in elderly patients

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Codeine Phosphate

Nervous System Disorders

• Drowsiness
• Confusion
• Restlessness
• Changes of mood
• Myosis
• Raised intracranial pressure
• Euphoria

Gastrointestinal Disorders

• Nausea and vomiting
• Constipation
• Dry mouth

Renal and Urinary Disorders

• Difficulty in micturition
• Ureteric or biliary spasm
• Antidiuretic effect

Skin and Subcutaneous Tissue Disorders

• Sweating
• Facial flushing
• Pruritus
• Urticaria

Cardiovascular Disorders

• Bradycardia
• Palpitations
• Orthostatic hypotension
• Hypothermia

Ear and Labyrinth Disorders

• Vertigo

Psychiatric Disorders

• Psychological and physical dependence (with repeated use)
• Withdrawal symptoms (upon discontinuation after long term misuse)

Mepyramine maleate

Nervous System Disorders

• Sedation (varying from slight drowsiness to deep sleep)
• Inability to concentrate
• Lassitude
• Dizziness
• Muscular weakness
• Incoordination
• Headaches
• Elation or depression
• Irritability
• Nightmares
• Paradoxical CNS stimulation (especially in children) with insomnia, nervousness, euphoria, irritability, tremors, and rarely nightmares, hallucinations, and convulsions
• Cerebral stimulation in infants and children
• Fits in epileptics (with large doses)

Cardiovascular Disorders

• Hypotension

Gastrointestinal Disorders

• Gastro-intestinal disturbances
• Nausea and vomiting
• Diarrhoea or constipation
• Epigastric pain
• Dryness of the mouth

Eye Disorders

• Blurred vision

Ear and Labyrinth Disorders

• Tinnitus

Renal and Urinary Disorders

• Difficulty in micturition

Metabolism and Nutrition Disorders

• Anorexia

General Disorders and Administration Site Conditions

• Tightness of the chest
• Tingling and heaviness of the hands

• Monoamine oxidase inhibitors
• Cardiac glycosides
• Quinidine
• Cyclopropane
• Halothane
• Halogenated anaesthetics
• Anaesthetics
• Hypnotics
• Sedatives
• Tricyclic antidepressants
• Phenothiazines

Other interactions

• Alcohol
• Skin tests
  (See additional prescribing points)

None routine

Skin test results

• Antihistamines may suppress positive skin test results and should be stopped several days before the test

Codeine phosphate
Codeine is a centrally acting narcotic antitussive which directly suppresses the medullary cough centre.

Mepyramine maleate
Mepyramine maleate is an antihistaminic.

COMBINATION PREPARATIONS

Codeine phosphate/ Mepyramine maleate

Syrup (per 5ml) 7mg/2.5mg

• Codomill (Trinity) originator